The Effect of Traxi Panniculus Retractor on Surgical Time at Non-emergent Cesarean Delivery in Obese Women

Not Applicable

Withdrawn

• Conditions: Obesity
• Interventions: Other: Silk Tape; Other: Traxi Panniculus Retractor (TPR)

• Registration Number: NCT04458415
• Lead Sponsor: Geisinger Clinic

Brief Summary

This is an unblinded, randomized control trial of obese women to evaluate the impact of the Traxi Panniculus Retractor (TPR) on the cesarean operative time and surgical blood loss when compared to silk tape.

Detailed Description

The purpose of the study is to assess whether using the Traxi Panniculus Retractor during cesarean section, in obese (BMI greater than or equal to 30kg/m2 at time of delivery) women, can decrease the cesarean operative time compared to using silk tape to retract the panniculus. Operative time is defined as the time from when the patient lies on the operating room table (at completion of the epidural/spinal anesthesia) until fascial closure.

Study Timeline

• Study First Submitted: 2020-06-11
• Study First Submitted QC: 2020-06-30
• Study First Posted: 2020-07-07
• Study Start: 2021-06-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-11
• Primary Completion: 2022-01-30
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Current BMI equal to or greater than 30 kg/m2 at last prenatal visit or on day of admission to L&D
• Requires panniculus retractor for cesarean delivery, as determined by the surgeon
• Non-emergent cesarean delivery
• Spinal or epidural anesthesia
• Low transverse skin incision
• Gestational age equal to or more than 32 weeks 0 days
• Singleton pregnancy
• Three or less previous cesarean deliveries.
• English speaking

Exclusion Criteria

• Use of Alexis or any other retractor
• General anesthesia
• Fetal demise
• Placenta previa
• History of bariatric surgery
• Adhesive allergy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silk Tape Arm	Silk Tape	Surgeon will use silk tape to retract the panniculus during cesarean section.
TPR Arm	Traxi Panniculus Retractor (TPR)	Surgeon will use the Traxi Panniculus Retractor to retract the panniculus during cesarean section.

Primary Outcome Measures

Name	Time	Method
Time from when a subject lies on the OR table to fascial closure	During surgery-Time from when a subject lies on the OR table to fascial closure

Secondary Outcome Measures

Name	Time	Method
Time from skin incision to skin closure	During surgery-skin incision to skin closure
Time from skin incision to closure of fascia	During surgery-skin incision to closure of fascia
Time from skin incision to delivery	During surgery-skin incision to delivery
Time from hysterotomy to delivery	During surgery-hysterotomy to delivery

Trial Locations

Locations (1)

Geisinger Medical Center; 🇺🇸 Danville, Pennsylvania, United States